Soft contact lens solution containing hyaluronic acid

ABSTRACT

A contact lens kit may include one or more soft contact lenses stored in an ophthalmologically acceptable solution of hyaluronic acid or a salt of hyaluronic acid. A method of disinfecting a soft contact lens, storing a soft contact lens, or facilitating insertion of a soft contact lens in an eye, may include placing the soft contact lens into an ophthalmologically acceptable solution that comprises (a) hyaluronic acid or a salt of hyaluronic acid, and (b) at least one compound to disinfect, store, or facilitate insertion of the contact lens.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a division of U.S. application Ser. No.10/615,592, filed Jul. 8, 2003, now U.S. Pat. No. 7,569,212, which isincorporated herein by reference and which is a continuation ofInternational Application No. PCT/NL02/00012, filed Jan. 9, 2002, whichis incorporated herein by reference and which claims the benefit ofNetherlands Application No. NL1017060, filed Jan. 9, 2001.

BACKGROUND

The current invention provides a procedure for the manufacture ofcontact lenses for eye treatment, eye protection and/or eye-care. Theinvention also provides a composition for the impregnation of a contactlens for the treatment and/or care and/or protection of the eye, a kitcontaining such a composition and one or more contact lenses as well ascontact lenses impregnated with the composition.

Because they regularly have unusual objects in their eyes for yearscontact lens wearers have a higher chance of damaging their cornea,eye-stratum, the endothelium or other parts of the eyes thannon-wearers, for example because chemical substances which may causeirritation or damage to the eye could be released from the lens or thesurface of the lens after inserting the lens into the eyes. Lenses whichhave not been properly cleaned or damaged lenses as well asdust-particles, traces of sand or pollen which have gotten under thelens could also affect the cornea. These damages or irritations can besuperficial and temporary, but could also result in far-reachingconsequences since lenses are usually worn daily. Health risks couldoccur, varying from irritated and red eyes to serious complications suchas permanent damage of the cornea resulting in blindness.

The cause of such complications is multifarious. Placing the contactlens onto the eye disturbs its physiological condition. Afterhabituation a new balance will be reached that can be disturbed again byvarious factors, such as ageing of the contact lens, damage to anddeposit on the lens, change of tear-flow with respect to composition andquantity due to frequency and manner of winking, chemical toxicity ofsubstances the user is in contact with, mechanical pressure and chroniclack of oxygen. The ageing of the user may bring about changes in his orher eyes thereby disturbing the physiological balance. The use ofmedication or the development of allergies may also lead to irritationsor damage of parts of the eyes.

Because nowadays contact lenses are frequently used for longer periodsof time careful and regular cleaning has become more important. If thisis not done sufficiently, bacteria, proteins etc., for instance, maycause irritations and damage more promptly. To prevent permanent damageit is vital that possible damage to the cornea or other parts of theeyes is treated as soon as possible.

Moreover, contact lens wearers may need extra protection for their eyes.It could be useful to the eyes to dispense extra nutrition, such asvitamins and provitamins or, additionally, those substances which offerprotection or allow, support or accelerate the repair of an occurringdamage. In eye healthcare several products are known to assist in theaccelerated recovery of the soundness of the cornea. These products,however, usually have to be administered (dripped in or applied onto theeye) separately or have to be swallowed by the user.

SUMMARY

It is the aim of the current invention to provide the opportunity for along-term care or treatment and/or protection and/or care of the eyes.

In accordance with one aspect of the present invention, a method for theproduction of contact lenses for the treatment and/or care and/orprotection of the eye may comprise the impregnation of contact lenses ina solution which comprises one or more suitable components for thetreatment and/or care and/or protection of the eye.

In accordance with another aspect of the present invention, acomposition for the treatment and/or care and/or protection of the eyemay comprise at least one suitable component for the treatment and/orcare and/or protection of the eye.

In accordance with a further aspect of the present invention, a contactlens for treatment and/or care and/or protection of the eye may beimpregnated with a composition comprising at least one suitablecomponent for the treatment and/or care and/or protection of the eye.

DETAILED DESCRIPTION

Considering the possibilities of irritation and damage to the cornea,the stratum, the endothelium or other parts of the eyes are manifold,one requires protection, conditioning and whenever possible, restorationof the sustained damage to the eye. The current invention thereforeprovides a method for the manufacture of contact lenses for thetreatment and/or care and/or protection of the eyes, comprising theimpregnation of contact lenses in a solution which contains suitablecompounds for the treatment and/or care and/or protection of the eyes.By wearing contact lenses the compounds which treat and/or protectand/or care of the eyes will be in contact with part of the eyes. Thisway the lens will be a method of administering these compounds whichwill often imply a more long-lasting administering compared to currenteye-drops. The compounds mentioned can be either absorbed into the lensmaterial or be attached to them or both. The term “impregnate” in thisapplication refers to either of these or to a combination of both.

Furthermore the current invention provides a composition for theimpregnation of contact lenses for the treatment and/or care and/orprotection of the eyes, comprising compounds suitable for eye treatmentor care or protection.

The current invention offers various types of compounds dependent on thetype of treatment, care or protection required. For the benefit of theuser these compositions can be combined with the compounds usually usedfor disinfecting, cleaning, insertion, moisturizing, rinsing or storingof contact lenses, so that the user need not add these compoundsseparately. However, it is likewise possible to just impregnate thelenses with the above-mentioned care or treatment products to preventdamage caused by other cleaning-agents or disinfectants.

Compounds that can be applied, but are not limited to substances whichfeed or treat the eye or may improve, accelerate or initiate localdamage repair, or helps to avoid local damage or irritations of parts ofthe eye, are: for instance dexpanthenol, pantothenic acid, hyaluronacid, retinol (Vitamin A) and retinyl derivatives, carotene, thiamine(Vitamin B1), riboflavine (Vitamin B2), pyridoxine (Vitamin B6),nicotinic acid, nicotine acidamin, biotine (Vitamin B7), niacinamide andniacine (vitamin ⁻B3), ascorbic acid (Vitamin C) and otheranti-oxidants, saccharose, honey and other bee products, red beetrootsyrup, collagen, gelatin, taurin, serine protease and other enzymes,propamidines, Vitamin D and its derivatives such as calciferol, VitaminK, tannin, pyruates, fibroplastin, fibronectine and fibrohydrolysate,heparin, alfa-ketaglutarine acid, carnisin, laminisin, mucin, tenascin,peptides epidermal growth factor (EGF), platelet-derived growth factor(PDGF), fibroblast growth factor (FGF), and all ophthalmologicallyacceptable salts and derivatives of the compounds mentioned above,selenium, calcium, zinc and other minerals.

Products used for maintenance and storage of contact lenses, likecleaning products and disinfecting solutions, and sprays, so-calledall-in-one solutions, storage liquids and rinsing liquids, insertionsolutions and moisturizers, neutralizers in either liquid or tabletform, gels, coatings and tablets which either make or assist in makingcontact lens solutions or make solutions come into being or are used foror in such solutions.

According to the current invention the composition can therefore appearin various forms, such as a solution, spray or tablet which afterdissolution makes a solution. Compounds intended for the care of contactlenses may also be part of a tablet which is combined with a solutionthat contains the care, treatment or protection agent or the reverse.Obviously both could also be included in one tablet or in separatetablets. Even so compounds can be included in a solution that is to bemixed with a solution without a compound.

Since the current substances which necessarily have to be applied fortheir germicidal and preservative effects in eye-care solutions,eye-drops and contact lens care solutions and which are germicidal in ashort period of time and sufficiently limiting increase in germpopulation usually have the disadvantage of causing irritation or evenattacking the eye to a large or lesser degree it would be greatlyadvantageous to use compounds in eyecare solutions, eye-drops andcontact lens solutions for germicidal or conservation purposes which arenon-irritant or protect against these irritations or damages. Possibledamage and irritation of the cornea or other parts of the eye will thusbe avoided. An additional aim of the current invention is to disclose amethod for improvement of the way a desired (and often necessary)antibacterial effect of a composition for contact lens care oreye-care/eye-drops can be reached. A number of peptides are naturallyfound in the eye. They have a protective effect on the eye andparticularly the cornea. The use of peptides in a composition for use ina contact lens solution, but also in eye-drops, could be greatlyadvantageous, because many peptides do not cause damage to the cornea;to some extent they also offer protection. They also offer protectionfrom and support against bacterial infections, especially for peopleprone to such infections or people whose corneas are easily damaged.

According to the current invention peptides can be used separately or incombination with other eye-care products or treatments.

The composition according to the current invention can be applied whenimpregnating all kinds of contact lenses, especially and preferably softlenses, but also hard lenses, disposable lenses and long-lasting ones aswell as extended wear lenses and intra-ocular lenses would benefit.Impregnation can be carried out by the user, for instance duringmaintenance, but also, as with new lenses, in the delivery packaging.

It is not necessary for the user using the contact lenses according tothe current invention to be already familiar with wearing lenses.People, and even animals, who in fact do not need any eye-correction,but who require for instance certain nutrients for the eye or productsto possibly initiate, support or accelerate healing sores or injuriescould wear contact lenses or similar objects according to the currentinvention on or in the eye to facilitate the required compound(s) on orinto the eye. It is not necessary for the active component with whichcontact lenses have been impregnated to repair or prevent any damage.Also medicines can be administered through a contact lens according tothe current invention. An example of another type of effective compound,in this case a medicine, which could be administered advantageously tothe eye according to the current invention is for instance cromoglycate.This compound works as a precautionary protection against allergies. Acontact lens with this compound could be used when the user expects anallergic reaction, for example in a period with high levels of pollen.Other compounds can be used as well to either prevent or reduce allergicreactions, such as emedastine, azelastine and nedocromil.

Other applications of contact lenses according to the current inventioncould be found in the treatment of so-called “dry eyes” or irritated orred eyes, hence called “dry eyes.” Currently mainly eye-drops are usedto treat this. Such eye-drops, however, usually offer only short-termrelief. In order to lengthen the availability of the active agents forthe treatment of the eyes several complex or expensive possibilities forslow-release eye-drops have been proposed. The contact lenses accordingto the current invention offer a simple, cheap and elegant alternative.

It could be particularly advantageous to use the compounds suggested inthe current invention as giving relief to dry eyes in combination withpolymers from which is known or believed that they, when used ineye-drops, offer relief, such as polymers of the typepolyvinylpyrrolidone (PVP), polyvinyl alcohol (PVA), hydroxypropylmethylcellulose (HPMC), hydroxy propyl cellulose (HPC), Carbomere orDextrane. Other substances that may be combined with the compoundsinclude polyhexamethylene biguanide hydrochloride (PHMB HCl), boricacid, borax, sodium chloride (NaCl), and ethylenediamine tetraaceticacid (EDTA).

As mentioned above contact lenses according to the current invention canalso be used to apply substances which cure or correct eye-diseases ordisorders and which should be administered once or several times a dayto take sufficient effect at least part of the day. The use of contactlenses according to the current invention could be effective here.Moreover, the use of contact lenses will generally result in a moreconstant level of the effective agent at the point of application thanwould have been possible with the use of eye-drops or even eye-balm.Eye-balm also has the disadvantages of causing limited eyesight directlyafter application and a less easy way of application for some userscompared to applying contact lenses. For wearers of contact lenses theuse of the current invention with their own lenses is particularlyeconomical, because they do not need to perform any supplementaryactions.

An advantage of the current invention is that the price of contactlenses has dropped considerably over the last few years especially thatof short-term use lenses such as the so-called day-lenses, week-lenses,month-lenses or three-months'-lenses. Such lenses are a preferableembodiment of the current invention.

The current invention will be illustrated in the following examples:

EXAMPLES

Examples of compositions to be used in the procedure according to thecurrent invention are the following:

A. All-In-One Solutions:

-   1. PHMB HCl 2.5 ppm-   2. Boric Acid 0.75%-   3. Borax 0.15%-   4. NaCl 0.40%-   5. EDTA-Na 0.03%-   6. HPMC 10,000 0.10%-   7. Dexpanthenol 1.0%-   8. pH adaptation with NaOH or HCl to pH 7.4

B. Neutralizers (Tablets):

-   1. Catalase 3000 IU-   2. KH2PO4 50 mg-   3. K2hPO4 150 mg-   4. NaCl q.s.-   5. Na-EDTA 0.2 mg-   6. Collagene 5 mg-   7. PVP K 90 10 mg

C. Storage Solutions and Insertion Solutions:

-   1. HPMC 4000 cP 0.2%-   2. Citric Acid 0.5%-   3. Na citrate 1.0%-   4. NaCl to 300 mOsm-   5. Na-EDTA 0.02%-   6. Alexidine 2 HCL 0.5 ppm-   7. Hyaluronic Acid 0.25%-   8. pH adaptation with NaOH or HCL ad pH 7.2

1. A contact lens kit comprising one or more soft contact lenses storedin an ophthalmologically acceptable solution of hyaluronic acid or asalt of hyaluronic acid.
 2. The kit of claim 1, wherein the solutionfurther comprises at least one compound to disinfect, store, orfacilitate insertion of a soft contact lens into an eye.
 3. The kit ofclaim 2, wherein the at least one compound comprises at least one ofpolyvinylpyrrolidone (PVP), polyvinyl alcohol (PVA), hydroxypropylmethylcellulose (HPMC), hydroxy propyl cellulose (HPC), carbomere, anddextrane.
 4. The kit of claim 1, wherein the one or more soft contactlenses are new lenses that are stored in the solution and packaged indelivery packaging.
 5. The kit of claim 1, wherein the solution furthercomprises dexpanthenol.
 6. The kit of claim 5, wherein the solutioncomprises at least 1% dexpanthenol by weight.
 7. The kit of claim 5,wherein the soft contact lens is a day lens.
 8. The kit of claim 5,wherein the solution is an all-in-one solution.
 9. The kit of claim 1,wherein the soft contact lens is a day lens.
 10. The kit of claim 1,wherein the solution is an all-in-one solution.
 11. A method ofdisinfecting a soft contact lens, storing a soft contact lens, orfacilitating insertion of a soft contact lens in an eye, comprisingplacing the soft contact lens into an ophthalmologically acceptablesolution that comprises (a) hyaluronic acid or a salt of hyaluronicacid, and (b) at least one compound to disinfect, store, or facilitateinsertion of the contact lens.
 12. The method of claim 11 wherein thesolution further comprises at least one of PVP, PVA, HPMC, HPC,carbomere, and dextrane.
 13. The method of claim 11, wherein thesolution comprises dexpanthenol.
 14. The method of claim 13, wherein thesolution comprises at least 1% dexpanthenol by weight.
 15. The method ofclaim 13, wherein the soft contact lens is a day lens.
 16. The method ofclaim 13, wherein the solution is an all-in-one solution.
 17. The methodof claim 11, wherein the soft contact lens is a day lens.
 18. The methodof claim 11, wherein the solution is an all-in-one solution.
 19. Themethod of claim 11, wherein the soft contact lens is placed in thesolution while the contact lens is not contacting an eye.
 20. The methodof claim 19, wherein the soft contact lens is a new lens and is in thesolution while in delivery packaging.